ON-Q* Pain Relief System with SOAKER* Catheter PS6506-N

GUDID 10193494000131

Avanos Medical, Inc.

Cardiac pulse generator programmer

• Primary Device ID: 10193494000131
• NIH Device Record Key: 14fdcf40-add0-45ff-8b9f-600f9869e6e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ON-Q* Pain Relief System with SOAKER* Catheter
• Version Model Number: PS6506-N
• Catalog Number: PS6506-N
• Company DUNS: 079375431
• Company Name: Avanos Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193494000134 [Primary]
GS1	10193494000131 [Package]; Contains: 00193494000134; Package: CS [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063530

FDA Product Code

• MEB: Pump, infusion, elastomeric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-23

Devices Manufactured by Avanos Medical, Inc.

• 10350770006076 - MIC PEG TUBE: 2025-03-04 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 14 Fr - PULL
• 10350770006083 - MIC PEG TUBE: 2025-03-04 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 24 Fr - PUSH OTW
• 10350770006090 - MIC PEG TUBE: 2025-03-04 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 24 Fr - PULL
• 10350770006120 - MIC PEG TUBE: 2025-03-04 MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 24 Fr - PULL
• 10350770006137 - MIC PEG TUBE: 2025-03-04 MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 14 Fr - PUSH OTW
• 10350770006144 - MIC PEG TUBE: 2025-03-04 MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr - PUSH OTW
• 10350770006168 - MIC PEG TUBE: 2025-03-04 MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 14 Fr - PUSH OTW
• 10350770006175 - MIC PEG TUBE: 2025-03-04 MIC* Safety Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr - PULL